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PDA: A Global Association
Joint Regulators-Industry
Quality by Design
WorkshopIntroduction and Goals of the
Workshop
Jean-Louis ROBERT
Chair CHMP-CVMP QWP
Joint Regulators/Industry QbD Workshop28-29 January 2014 London, UK
Pharmaceutical Development a History
1989 Development Pharmaceutics (EU)
1999 Revision of Development Pharmaceutics (EU)
1998 Discussion on CTD-Q
Initial proposal → Pharmaceutical Development
under Regional Requirement!
Reminder: EU: dossier structure (before CTD)
1. Composition
2. Development Pharmaceutics
3. ……………………..
2005: Pharmaceutical Development
2
“Develop a harmonised pharmaceutical quality
system applicable across the lifecycle of the
product emphasizing an integrated approach to
quality risk management and science.”
Brussels July 2003
Quality by Design – Paradigm Change
3
Achievements
• Q8 (R2): pharmaceutical Development
– Principles, concepts, opportunities
• Q9: Quality Risk Management
– Proactive approach
• Q10: Pharmaceutical Quality System
– Based on ISO standards but including the lifecycle
• Q11: Development and manufacturing of APIs
– Q8 (R2) for APIs
4
© 2011 ICH
‘Points to consider’‘Questions and Answers’ ‘Training & Workshop’
5
From 2009 to 2011
ICH – Quality IWG implementation support
http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
“Application including QbD: A Leaning process
Quality by Design – Paradigm Change
• Quality must be mainly built in and it will not only improve by additional testing and inspection
• Better utilization of modern science throughout product lifecycle
• QRM is a key enabler throughout product lifecycle
• Robust PQS with appropriate knowledge management assures quality throughout product life cycle.
• An integrated approach to development, manufacturing and quality for both industry and regulators
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• Understanding of Quality by Design as in Q8(R2)– A more systematic approach to development may
include, for example, incorporation of prior knowledge, results of experimental studies using design of experiments, use of quality risk management, and use of knowledge management (see ICH Q10) throughout the lifecycle of product.
– Science is no longer isolated; it is living across the lifecycle of the product/process within a Quality Management System.
Quality by Design – Paradigm Change
7
Current Status (1)
• A lot of progress in the recent past
– More science based applications
– More scientific understanding (DoE)
• More robust manufacturing processes
– More emphasis on
• Control Strategy
• Opportunities:
– Real Time Release Testing
– Manufacturing flexibility (Design Space)
8
Current Status (2)
• However a lot of complaints (Regulators and Industry)
– More science but more questions !?!
– Level of data/information requested or submitted in an
application not really clarified.
– Quality of information submitted.
– Reason for a more systematic or QbD approach if no
benefit at the end.
– Is the term QbD unclear or not sometimes misused?
– Terminology!
9
ICH Informal Quality Discussion Group
• Forum for promoting QbD topics
• Identified QbD topics so far
(not a priority list, no decision taken):
– Revision of Q6A/B
– CTD-Q location
– Life-Cycle Management
– Process Validation
– Continuous Manufacturing
– QbD Analytical Methods/Analytical Validation
– Quality Glossary
• Training
10
Scope of Workshop
• Workshop based on real cases
• Survey/Wrap up of what has been achieved so far
• Experience gained so far
• Promotion of common understanding
• Identify bottlenecks/obstacles to QbD
• Identify next steps
• International harmonisation: participation of FDA/MHLW-
PMDA
11
Future Challenges
• QbD for biologicals: more discussion needed!?
• QbD for more "complex" type of products.
• How can we further promote this paradigm?
• International harmonisation: what about regions outside
ICH?
12
Thank you
• Organising Committee
• Presenters: Industry and Regulators
• PDA
• EMA for hosting
13
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